Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
33961–33984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2015
Hedgehog Cervical Interbody Fusion Device
K143685 · ODP
Vertera, Inc.
Orthopedic · 273d
Cleared Sep 23, 2015
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody...
K143736 · DHR
Immco Diagnostics, Inc.
Immunology · 267d
Cleared Sep 23, 2015
Solea
K151306 · GEX
Convergent Dental, Inc.
General & Plastic Surgery · 128d
Cleared Sep 23, 2015
UPT Series Medical RO Water System
K151637 · FIP
Specialty Water Technologies
Gastroenterology & Urology · 98d
Cleared Sep 23, 2015
Uberlube
K151647 · NUC
Uberlube, LLC
Obstetrics & Gynecology · 97d
Cleared Sep 23, 2015
Contour Next Control Solution
K151742 · JJX
Bayer Healthcare
Chemistry · 86d
Cleared Sep 23, 2015
CrossRoads Screw System
K152072 · HWC
Crossroads Extremity Systems, LLC
Orthopedic · 58d
Cleared Sep 23, 2015
Stretta Catheter
K152317 · GEI
Mederi Therapeutics, Inc.
General & Plastic Surgery · 37d
Cleared Sep 23, 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · DXN
Andon Health Co, Ltd.
Cardiovascular · 33d
Cleared Sep 23, 2015
Infinity Delta, Infinity Delta XL, Infinity Kappa
K152407 · MHX
Draeger Medical Sytems, Inc.
Cardiovascular · 29d
Cleared Sep 23, 2015
Sydney IVF PVP
K152440 · MQL
Willam A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 27d
Cleared Sep 22, 2015
Universal Light Handle Cover, Light Handle Cover
K150532 · FTA
Key Surgical, Inc.
General & Plastic Surgery · 204d
Cleared Sep 22, 2015
HEARTWAY Power Mobility Scooter, BRIO S19
K150987 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 161d
Cleared CT Sep 22, 2015
ZELTIQ CoolSculpting System
K151179 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 141d
Cleared Sep 22, 2015
Destino Reach
K151951 · DYB
Oscor, Inc.
Cardiovascular · 69d
Cleared Sep 22, 2015
Permanent Sled Bag
K152403 · ITX
Boston Scientific
Radiology · 28d
Cleared Sep 21, 2015
TM eCloud ECG Analysis System
K142349 · DQK
Telemed Solutions, Inc.
Cardiovascular · 395d
Cleared Sep 21, 2015
Anker Dental Implant System - SB-III, ST and AT series
K142557 · DZE
Alliance Global Technology Co., Ltd.
Dental · 375d
Cleared Sep 21, 2015
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
K143754 · NHX
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Sep 21, 2015
Phoenix XL Dialysate Meter
K150657 · FIZ
Mesa Laboratories, Inc.
Gastroenterology & Urology · 192d
Cleared Sep 21, 2015
OsteoMed IMF Screw
K151195 · DZL
Osteomed
Dental · 140d
Cleared Sep 21, 2015
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · ELW
Osstem Implant Co., Ltd.
Dental · 131d
Cleared Sep 21, 2015
ZelanteDVT Thrombectomy Set
K151313 · QEW
Boston Scientific Corporation
Cardiovascular · 126d
Cleared Sep 21, 2015
Prestige
K151514 · EBF
Danville Materials, LLC
Dental · 108d